Additional electrolyte supplier for pulse generator batteries, an approved manufacturing location for the existing battery electrolyte supplier, and updates to associated acceptance activities.
| Device | EMBLEM SICD GEN 2, SICD EMBLEM MRI , Subcutaneous Implantable Cardioverter Defibrillator (SICD) |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC CORPORATION |
| Date Received | 2017-11-20 |
| Decision Date | 2017-12-06 |
| PMA | P110042 |
| Supplement | S097 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC CORPORATION 4100 Hamline Avenue North st. Paul, MN 55112-5798 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P110042 | | Original Filing |
| S177 |
2022-12-07 |
30-day Notice |
| S176 |
2022-11-10 |
30-day Notice |
| S175 |
2022-10-05 |
30-day Notice |
| S174 | | |
| S173 | | |
| S172 |
2022-09-20 |
30-day Notice |
| S171 |
2022-06-29 |
30-day Notice |
| S170 |
2022-06-16 |
30-day Notice |
| S169 |
2022-04-25 |
Normal 180 Day Track No User Fee |
| S168 |
2021-12-16 |
30-day Notice |
| S167 | | |
| S166 | | |
| S165 |
2021-10-08 |
30-day Notice |
| S164 | | |
| S163 |
2021-09-30 |
30-day Notice |
| S162 |
2021-09-23 |
30-day Notice |
| S161 | | |
| S160 | | |
| S159 | | |
| S158 |
2021-09-01 |
30-day Notice |
| S157 |
2021-06-21 |
Real-time Process |
| S156 |
2021-04-26 |
30-day Notice |
| S155 |
2021-03-29 |
30-day Notice |
| S154 | | |
| S153 |
2021-03-08 |
30-day Notice |
| S152 |
2021-01-11 |
30-day Notice |
| S151 |
2020-12-10 |
30-day Notice |
| S150 | | |
| S149 |
2020-11-03 |
30-day Notice |
| S148 | | |
| S147 | | |
| S146 |
2020-09-24 |
30-day Notice |
| S145 |
2020-08-25 |
30-day Notice |
| S144 | | |
| S143 | | |
| S142 | | |
| S141 |
2020-07-27 |
30-day Notice |
| S140 |
2020-07-08 |
30-day Notice |
| S139 |
2020-06-24 |
30-day Notice |
| S138 |
2020-05-27 |
30-day Notice |
| S137 | | |
| S136 |
2020-04-06 |
30-day Notice |
| S135 |
2020-03-13 |
30-day Notice |
| S134 |
2020-03-02 |
30-day Notice |
| S133 | | |
| S132 |
2019-12-23 |
Normal 180 Day Track |
| S131 |
2019-11-22 |
30-day Notice |
| S130 |
2019-10-21 |
30-day Notice |
| S129 | | |
| S128 |
2019-09-18 |
30-day Notice |
| S127 |
2019-08-30 |
30-day Notice |
| S126 |
2019-06-14 |
30-day Notice |
| S125 |
2019-03-20 |
Real-time Process |
| S124 |
2019-03-13 |
30-day Notice |
| S123 |
2019-03-04 |
Real-time Process |
| S122 |
2019-03-01 |
30-day Notice |
| S121 |
2018-12-26 |
30-day Notice |
| S120 |
2018-12-26 |
Real-time Process |
| S119 |
2018-12-03 |
Real-time Process |
| S118 |
2018-11-27 |
30-day Notice |
| S117 |
2018-11-08 |
30-day Notice |
| S116 |
2018-10-19 |
30-day Notice |
| S115 |
2018-10-05 |
30-day Notice |
| S114 |
2018-09-26 |
30-day Notice |
| S113 |
2018-09-04 |
30-day Notice |
| S112 |
2018-08-30 |
30-day Notice |
| S111 |
2018-07-13 |
30-day Notice |
| S110 |
2018-05-22 |
30-day Notice |
| S109 |
2018-05-07 |
30-day Notice |
| S108 |
2018-05-02 |
30-day Notice |
| S107 |
2018-04-17 |
30-day Notice |
| S106 |
2018-03-26 |
30-day Notice |
| S105 |
2018-03-05 |
30-day Notice |
| S104 |
2018-02-16 |
30-day Notice |
| S103 |
2018-01-19 |
30-day Notice |
| S102 |
2017-12-19 |
Normal 180 Day Track |
| S101 |
2017-12-19 |
30-day Notice |
| S100 |
2017-12-18 |
30-day Notice |
| S099 |
2017-12-18 |
30-day Notice |
| S098 |
2017-11-21 |
30-day Notice |
| S097 |
2017-11-20 |
30-day Notice |
| S096 |
2017-11-02 |
30-day Notice |
| S095 |
2017-10-30 |
30-day Notice |
| S094 |
2017-09-28 |
30-day Notice |
| S093 |
2017-09-20 |
30-day Notice |
| S092 |
2017-09-15 |
Real-time Process |
| S091 |
2017-08-04 |
30-day Notice |
| S090 |
2017-07-24 |
30-day Notice |
| S089 |
2017-07-18 |
Real-time Process |
| S088 |
2017-07-17 |
Real-time Process |
| S087 |
2017-06-07 |
Real-time Process |
| S086 |
2017-05-22 |
Real-time Process |
| S085 |
2017-05-10 |
30-day Notice |
| S084 |
2017-04-28 |
30-day Notice |
| S083 |
2017-04-03 |
Normal 180 Day Track |
| S082 |
2017-03-29 |
30-day Notice |
| S081 |
2017-03-27 |
30-day Notice |
| S080 |
2017-03-27 |
Real-time Process |
| S079 |
2017-02-22 |
30-day Notice |
| S078 |
2017-02-07 |
30-day Notice |
| S077 |
2017-02-06 |
Normal 180 Day Track |
| S076 |
2017-02-03 |
30-day Notice |
| S075 |
2017-01-23 |
30-day Notice |
| S074 |
2016-12-20 |
30-day Notice |
| S073 |
2016-12-19 |
30-day Notice |
| S072 |
2016-12-14 |
30-day Notice |
| S071 |
2016-11-22 |
30-day Notice |
| S070 |
2016-11-22 |
Real-time Process |
| S069 |
2016-10-31 |
30-day Notice |
| S068 |
2016-10-26 |
Normal 180 Day Track |
| S067 |
2016-10-19 |
Normal 180 Day Track |
| S066 |
2016-10-03 |
30-day Notice |
| S065 |
2016-09-16 |
30-day Notice |
| S064 |
2016-09-12 |
30-day Notice |
| S063 |
2016-09-02 |
30-day Notice |
| S062 |
2016-08-17 |
30-day Notice |
| S061 |
2016-07-07 |
30-day Notice |
| S060 |
2016-07-01 |
Real-time Process |
| S059 |
2016-04-21 |
Real-time Process |
| S058 |
2016-02-12 |
Normal 180 Day Track |
| S057 |
2015-12-21 |
Real-time Process |
| S056 |
2015-11-13 |
30-day Notice |
| S055 |
2015-11-04 |
30-day Notice |
| S054 | | |
| S053 |
2015-10-14 |
30-day Notice |
| S052 |
2015-09-30 |
30-day Notice |
| S051 |
2015-09-23 |
30-day Notice |
| S050 |
2015-09-17 |
30-day Notice |
| S049 |
2015-07-29 |
30-day Notice |
| S048 | | |
| S047 | | |
| S046 | | |
| S045 |
2015-04-27 |
Real-time Process |
| S044 | | |
| S043 |
2014-11-14 |
Normal 180 Day Track |
| S042 |
2014-11-03 |
30-day Notice |
| S041 |
2014-09-29 |
30-day Notice |
| S040 |
2014-08-11 |
30-day Notice |
| S039 |
2014-06-16 |
Special (immediate Track) |
| S038 |
2014-06-12 |
Normal 180 Day Track No User Fee |
| S037 |
2014-06-02 |
30-day Notice |
| S036 | | |
| S035 |
2014-05-08 |
30-day Notice |
| S034 |
2014-05-08 |
30-day Notice |
| S033 |
2014-05-05 |
30-day Notice |
| S032 |
2014-04-14 |
30-day Notice |
| S031 |
2014-04-09 |
30-day Notice |
| S030 | | |
| S029 |
2014-03-18 |
Normal 180 Day Track |
| S028 |
2014-03-18 |
30-day Notice |
| S027 |
2014-02-21 |
30-day Notice |
| S026 |
2014-01-14 |
30-day Notice |
| S025 |
2014-01-10 |
30-day Notice |
| S024 |
2013-12-23 |
30-day Notice |
| S023 |
2013-11-20 |
30-day Notice |
| S022 |
2013-11-13 |
30-day Notice |
| S021 |
2013-11-06 |
30-day Notice |
| S020 |
2013-11-06 |
Normal 180 Day Track |
| S019 |
2013-10-30 |
30-day Notice |
| S018 |
2013-10-23 |
30-day Notice |
| S017 |
2013-09-03 |
Normal 180 Day Track No User Fee |
| S016 |
2013-09-03 |
Real-time Process |
| S015 |
2013-08-30 |
30-day Notice |
| S014 |
2013-08-05 |
Real-time Process |
| S013 |
2013-08-01 |
30-day Notice |
| S012 |
2013-07-02 |
Real-time Process |
| S011 |
2013-06-21 |
Real-time Process |
| S010 |
2013-06-14 |
30-day Notice |
| S009 |
2013-06-10 |
Normal 180 Day Track |
| S008 |
2013-04-22 |
30-day Notice |
| S007 |
2013-04-04 |
Real-time Process |
| S006 |
2013-03-18 |
30-day Notice |
| S005 |
2013-02-28 |
Real-time Process |
| S004 |
2013-01-11 |
Real-time Process |
| S003 |
2012-12-13 |
Real-time Process |
| S002 |
2012-12-10 |
Normal 180 Day Track |
| S001 |
2012-11-13 |
30-day Notice |
NIH GUDID Devices